MAUDE Adverse Event Report: LENSAR, INC LENSAR LASER SYSTEM-FS 3D

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Capsular Bag Tear (2639)

Event Date 06/01/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, while cas was on-site dr.(b)(6) noticed a posterior capsular rupture on procedure id:(b)(6).

Manufacturer Narrative

Measure: this issue only impacts this specific device.Analyze: (b)(6) reviewed the open call for lls5035.Procedure #7574 - suction ring placement was well centered with adequate suction holding throughout the procedure.Mild patient movement noted.Capsulotomy begins in frame #3 with full breakthrough in frame #7.Lens fragmentation follows.No planned ak incisions.Root cause: surgical technique and improper hydrodissection could result in gas bubbles in the posterior.Laser functioned as designed.Improve/innovate/control: (b)(6) to discuss findings with surgeon and staff.No further follow up.

• Brand Name: LENSAR LASER SYSTEM-FS 3D
• Type of Device: LENSAR LASER SYSTEM-FS 3D
• Manufacturer (Section D): LENSAR, INC; 2800 discovery drive ste.100; orlando FL 32826
• Manufacturer (Section G): LENSAR, INC; 2800 discovery drive ste. 100; orlando FL 32826
• MDR Report Key: 17240290
• MDR Text Key: 318342138
• Report Number: 3009026057-2023-55779
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 70-00005-001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other